New Drugs of Norvatis for Multiple Sclerosis have Significantly Improved the Condition of Children

Today, Norvatis announced results of a three-phase clinical study of PARADIGMS. The study assessed safety and efficacy of Gilenya (fingolimod) in children and adolescents (ages 10 to 17 years) compared with beta-1a interferon. The results showed that the annual recurrence rate decreased by 82 percent (p < 0.001) compared with the patients receiving intramuscular injection of beta-1a interferon. The first randomized controlled clinical trial was conducted for pediatric patients. results of the clinical trial were made public at the 7th European and American multiple sclerosis joint treatment and research commission (ectrims-actrims) meeting in Paris, France, on October 28, 2017.

Multiple sclerosis is a chronic central nervous system disease, it disrupts normal functioning of the brain, optic nerve and spinal cord through inflammation and tissue loss. MS is affecting about 2.3 million people around the world, with an estimated 3-5 per cent of children and there is no cure for the disease. Among adults, there are three types of MS: relapsed MS (RRMS), secondary progressive MS (SPMS), and original progressive MS (PPMS). And in children, almost all cases (about 98%) are RRMS.

Gilenya is the first oral disease modification therapy (DMT) approved for multiple sclerosis. Gilenya has a reversible lymphocyte redistributive effect on focal and diffuse central nervous system damage caused by MS. Long-term clinical trials, real-world evidence and treatment experience suggest that Gilenya can be easily integrated into the patient's daily life. It leads to high treatment satisfaction, long-term adherence, and ultimately improves the long-term prognosis of patients.

The study on (NCT01892722) is a flexible course (2 years), double blind, randomized, multi-center phase 3 clinical, which is carried out in 87 branches in 25 countries. In the study, , efficacy and safety of the oral Gilenya relative to beta-1a interferon muscle injection was evaluated in children and adolescents diagnosed with multiple sclerosis. The study has a five-year open label extension. A total of 215 children and adolescents were enrolled in the study, aged between 10 and 17, with an expanded disability status scale (EDSS) score between 0 and 5.5. patients were randomly assigned to an oral Gilenya group(0.5 mg or 0.25 mg, depending on the patient's weight) or a weekly muscle injection of beta-1a interferon group. The main endpoint of the study was the recurrence rate (annual recurrence rate, ARR) for 24 months. Secondary endpoints include new or new expanded T2 lesions, gadolinium-enhanced T1 lesions, safety and pharmacokinetic properties, all these indicators are evaluated throughout the treatment period.

Compared to patients treated with beta-1a interferon, magnetic resonance imaging (MRI) measurements indicated that the number of patients receiving Gilenya treatment raised up significantly with the increase in T2 and gd-t1 lesions. The number and volume of lesions are closely related to the recurrence of disease and disability. In addition, patients receiving Gilenya treatment had significantly reduced brain shrinkage, and adult brain shrinkage was associated with loss of body and cognitive function. The safety of Gilenya was consistent with previous clinical trial results, and there were more adverse events reported in the interferon group. In another analysis group, Gilenya significantly delayed Disability Progression compared to beta-1a interferon (CDP).